Scientist Drug Safety (Temporary) Full-time

Scientist Level Clinical Safety Scientist

The Scientist Level Clinical Safety Scientist (CSS) is responsible for support of safety reporting in clinical trials conducted in multiple therapeutic areas as part of investigational product development programs across early and late-stage development. Assists the protocol lead in safety reporting activities for multiple clinical trials. The CSS may support collaboration with cross-functional colleagues within clinical development, clinical operations, case processing and medical safety review.

Key Responsibilities:

• Intake of reportable safety event information from clinical trial investigator sites.
• Review and manage individual case safety reports for each event.
• Ensure that all information required for a clinically complete and accurate case is present.
• Generate safety queries to the trial investigator sites to ensure case report accuracy and completeness.
• Prioritize daily work to ensure all events are submitted for entry into the safety database within the established timeframes.
• May collaborate with cross-functional colleagues as needed.
• Complete protocol-specific activities as required.
• Actively participate and ensure effective communication with the protocol lead and other team members supporting their protocols.
• Appropriately escalate protocol or individual event issues with other stakeholders, including CRAs/CRMs or protocol leads.

Qualifications & Skills

• Understanding of scientific and medical concepts
• Basic understanding of drug development
• Basic knowledge of GCP and ICH regulations
• Ability to work as part of a cross-functional team.
• Ability to identify and escalate problems and contribute to issue resolution.
• Time management and organizational skills.
• Strong communication skills with advanced oral and written English skills.
• Advanced computer and database skills
• Independent, strong analytical, and problem-solving skills
• Able to work under the pressure, strong sense of responsibility and accountability.

Education Requirement:

• M.D. with minimum 1 year of clinical work experience in a patient care setting or 2 years relevant pharmaceutical, drug development, and/or drug safety experience.

Work Experience:

• Minimum 1 year of Experience in a patient care setting, drug safety, and/or pharmaceutical drug development.

Required Skills:

Accountability, Biological Sciences, Clinical Development, Clinical Reporting, Clinical Safety, Clinical Trials, Clinical Trials Monitoring, Cross-Functional Collaboration, Detail-Oriented, Drug Development, English as a Foreign Language, Life Science, Pharmaceutical Development, Pharmacotherapeutics, Pressure Management, Product Development, Teamwork, Time Management, Works Under Pressure

Preferred Skills:

Safety Reporting